ISO/DTS 24943

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ISO/TC 249/SC 1
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ISO/CD TS 24943(en)
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Secretariat:  SAC
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Date: 2025-12-15
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Traditional Chinese medicine — Requirements for decoction pieces
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prescription
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ISO/CD TSDTS 24943:2025(en)
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Published in Switzerland
ii
ISO/CD TSDTS 24943:2025(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
General requirements . iii
Acquisition of the right to prescription . iii
Drawing up of prescription . iii
Printing of the prescription . iii
Timeliness of the prescription. iii
Revision of the prescription . iii
Preservation and destruction of the prescription . iii
Content and writing requirements for prescription of Chinese Medicines . iii
Contents of prescription of Chinese medicines . iii
Requirements of prescription of Chinese medicines writing . iii
Prescription writing requirements for finished Chinese medicinal product . iii
Writing Format of prescription of Chinese medicines . iii
Management of prescription rightsof Chinese medicine, the qualification for dispensation
and delivery . iii
Management of prescription right of Chinese medicine . iii
Requirements for narcotic drugs prescription and toxic drugs prescription . iii
(informative) Prescription patterns and writing examples of Chinese Medicines in TCM clinics . iii
(informative) Requirements for narcotic/toxic Chinese medicines prescription in China . iii
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Acquisition of the right to prescription . 2
4.2 Drawing up of prescription . 2
4.3 Printing of the prescription . 2
4.4 Timeliness of the prescription . 2
4.5 Revision of the prescription . 2
4.6 Preservation and destruction of the prescription . 2
5 Content and writing requirements for prescription of Chinese Medicines . 2
5.1 Contents of prescription of Chinese medicines . 2
5.2 Prescription of Chinese medicines writing requirements . 3
5.3 Prescription writing requirements for finished Chinese medicinal product . 3
5.4 Written format of the prescription of Chinese medicines . 4
6 Management of prescription rights for Chinese medicine and qualification for
dispensation and delivery . 4
6.1 Modification of the prescription. 4
iii
ISO/CD TSDTS 24943:2025(en)
6.2 Herbal dispensary personnel . 4
7 Requirements for the prescription of narcotic drugs and toxic drugs . 5
Annex A (informative) Prescription patterns and writing examples of Chinese medicines in TCM
clinics. 6
Annex B (informative) Requirements for narcotic or toxic Chinese medicines prescription in
China . 10
Bibliography . 18

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ISO/CD TSDTS 24943:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1Part 1. In particular, the different approval criteria needed for the different
types of ISO document should be noted. This document was drafted in accordance with the editorial rules of
the ISO/IEC Directives, Part 2IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of (a)
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This document was prepared by Technical Committee ISO/TC 249，Tradiotional, Traditional medicine,
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Subcommittee SC 1, Traditional Chinese medicine.
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A list of all parts in the ISO/CD TS 24943 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/CD TSDTS 24943:2025(en)
Introduction
The prescription requirements of Chinese medicines are a crucial component of the service process of Chinese
medicines. This encompasses the whole process, starting from the physician's medical treatment guided by
the traditional Chinese medicine (TCM) theory of syndrome differentiation and treatment, leading to the
writing of the patient prescription. Unfortunately, this aspect has not received adequate attention,
significantly affecting the quality of medical care and services, as well as the safety and effectiveness of TCM
medication, and the vital rights of consumers.
Therefore, it is vital to standardize and establish a traceable medication service process offor Chinese
medicines. This promoteswill promote effective communication among physicians, pharmacists and patients,
improving relationshiprelationships between physicians and patients, enhancing level of medical service,
improving the levellevels of medical service, reducing medical errors and accidents, ensuring the safety and
effectiveness of people's medication, safeguarding the legitimate rights and interests of consumers, and
making contributions to human health.
Prescribing is an important medical activity that requires seriousnessserious and rigorous behavior. It’sIt is
also the first and most critical step in the entire service process.
This document is consistent with ISO 18668-2 "Traditional Chinese medicine—Coding System for Chinese
Medicines—Part 2: Codes for decoction Pieces", ISO 18668-4 “Traditional Chinese medicine—Coding system for
Chinese medicines— Part 4: Codes for granule forms of individual medicinal for prescriptions”, ISO 20333
“Traditional Chinese medicine—Coding rules for Chinese medicines in supply chain management”, ISO 20334
“Traditional Chinese medicine—Coding system of formulae”the provisions of ISO 18668-2, ISO 18668-4, ISO
20333, ISO 20334 and other relevant international standards.
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ISO/CD TSDTS 24943:2025(en)
Traditional Chinese medicine — Requirements for decoction pieces
prescription
1 Scope
This document specifies the general requirements, content, and writing requirementrequirements for the
prescription of decoction pieces prescriptions. It notably regulates the qualification of prescription writing,
the prescription of precious medicines, the prescription of toxic and anestheticanaesthetic medicines, and
institution-based prescription, etcprescriptions.
This document applies to prescription writing, dispensing and storage.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— — ISO Online browsing platform: available at
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http://www.iso.org/obphttps://www.iso.org/obp
3.1
Prescription— IEC Electropedia: available at https://www.electropedia.org/
3.1
prescription of Chinese medicines
A medical document issued by a licensedlicenced physician for the diagnosis and treatment of patients.
Note 1 to entry: The medical documentprescription of Chinese medicines includes details such as the names, quantities,
preparation methods, and other specifications of Chinese medicinal herbs and formulations. This documentIt is subject
to review, dispensation, and verification by a prescription -reviewing pharmacist, (see Note 4 to entry), and it also serves
as a voucher for the distribution of medicinal products.
Note 2 to entry: The prescription of Chinese Medicinesmedicines is not only a written notice from doctors to
TCMtraditional Chinese medicine dispensing personnel, describing the prescription of decoction pieces, but it is also (see
Note 5 to entry) that represents both the basis of TCMtraditional Chinese medicine dispensing, as well asand the voucher
of valuation and statistics, which has legal, technical and economic significance.
Note 3 to entry: The prescription of Chinese Medicines aremedicines provides a written recordsrecord and evidence of
doctors’ syndrome differentiation and treatment, reflecting the physicians' syndrome differentiation and drug use
requirements.
Note 4 to entry: The "prescription -reviewing pharmacist" refers to a professional in the herbal pharmacy responsible
for reviewing physicians' prescriptionprescriptions.
Note 5 to entry: TCM"Traditional Chinese medicine dispensing personnel" refers to a professionalinprofessional in the
dispensing room responsible for the preparation, dispensing, and management of prescriptionprescriptions.
ISO/CD TSDTS 24943:2025(en)
4 General requirements
4.1 Acquisition of the right to prescription
Possessing correspondingIndividuals in possession of the relevant educational background and knowledge,
and havingwho have obtained themedical qualification of doctors in(s) according to the local health and
pharmaceutical industries, and who are employed by medical institutions, entitledare granted prescription
rights by that medical institution.
NOTE Employees of the medical institutions. can include freelance doctors, self-employed persons and owners of
Formatted: Note
medical institutions.
NOTE Employers Of Medical Institutions Include Freelance Doctors/Self-Employed Persons And Owners Of Medical
Institutions.
4.2 Drawing up of prescription
PhysicianA physician/doctor of traditional Chinese medicine should prescribe based on the principle of
syndrome differentiation and treatment, specific medical needs, prevention, health care, standard of diagnosis
and treatment, drug indication, pharmacological action, usage, dosage, contraindication, adverse reaction and
precautions, etc.
4.3 Printing of the prescription
Appropriate warning labels should be marked on prescriptions of narcotic and toxic drugs to ensure proper
handling and awareness of their special status and usage guidelines.
4.4 Timeliness of the prescription
Requirements for the timeliness of prescriptions should be specified based on the local situation.
4.5 Revision of the prescription
The prescription should be legibly written and should not be altered; in the event that theif amendment is
necessary, the prescriber mustshall sign and date the amended section to indicate the revision.
4.6 Preservation and destruction of the prescription
Medical institutions responsible for dispensing prescriptions are required to maintain them properly.
NOTE The retention period for different types of prescriptions should comply with thecan be dependent on
Formatted: Note
guidelines set by the medical and health administrative authorities of the respective country or region.
5 Content and writing requirements for prescription of Chinese Medicines
5.1 Contents of prescription of Chinese medicines
5.1.1 Precription contents
The preface, text and postscript of the prescription contain standardized content, specified in the following
subclauses, and shall adhere to the requirements of safety, efficiency, and cost-effectiveness.
5.1.2 Prescription preface
The prescription preface includes shall include:
a) the name of the medical treatment, prevention or health care institution,;
ISO/CD TSDTS 24943:2025(en)
b) the prescription number,;
c) the patient’s name, sex, and age and;
d) the patient's inpatient record number, department or ward and bed number,;
e) the patient's clinical diagnosis/TCM diagnosis, including the disease name and syndrome type (do not
write if the disease name is not clear), );
f) the date of prescribing, etc.
Formatted: List Number 1, Numbered + Level: 1 +
Numbering Style: a, b, c, … + Start at: 1 + Alignment:
5.1.3 Prescription text
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The prescription text isshall be marked with a distinctive heading or symbol to label the prescription, such as
‘Rp’"Rp" or ‘"R" (the abbreviation of Latin Recipe), and decoction"recipe"). Decoction pieces shall include
itstheir name, dosage and usage.
5.1.4 Prescription postscript
The prescription postscript encompasses shall encompass the physician’s signature and/or authorized stamp,
and itemsor both. Items with special requirements can be added according todepending on the actual
situation, such as price, drug amount, and signature and/or covered or the special signature of the
pharmaceutical professional and technical personnel for reviewing, dispensing, checking and distributing
drugs.
5.2 Requirements of prescriptionPrescription of Chinese medicines writing requirements
5.2.1 The name of the decoction pieces should be written in the official local language.
5.2.2 The dosage should be expressed in statutory unit of measurement, using Arabic numerals, the. The
principle should be in "gram"(" (g) as a unit, i.e. With "g" (unit name) following the numerical value.
5.2.3 The number of decoction pieces should be used as a "dose".
The quantity of doses should be specified directly, followed by the prescription’s usage and
dosageinstruction.dosage instruction. This includes daily dosage, dosage forms (decocting, wine-soaking,
powder-baking, pill-making, capsules-filling, etc.), dosage frequency of taking, medication methods (oral and
external use, etc.),.) and administration requirements (administered warm, administered cool, administered
at draught, slow administration, administered before meal, administered after meal, administered on empty
stomach, etc).).
EXAMPLE oneOne dose per day, decocting it with 400ml water, administered warm, in the morning and evening ".
5.2.4 TheRegarding the use of decoction pieces under the administration of toxic drugs and anesthetics
should be strictly observed by theanaesthetics, local relevant laws, regulations and regulations can apply.
5.2.5 ProhibitedRegarding prohibited or restricted use of certain decoction pieces should strictly comply
with the relevant, regulations of the local medical and health management departments of the country or
region can apply.
5.3 Prescription writing requirements for finished Chinese medicinal product
5.3.1 According to the TCM diagnosis of TCM (including disease name and syndrome type), syndrome
differentiation or a combination of syndrome differentiation and disease differentiation is used to select a
suitable finished Chinese medicinal product.
ISO/CD TSDTS 24943:2025(en)
5.3.2 The name of the decoction pieces in the hospital should be approved by the drug supervision and
administration department.
5.3.3 Usage and dosage should be used according to the conventional usage and dosage prescribed in the
drug instructions. WhenIf the patient has a special condition and needs to exceed the dosage, the reasons
should be noted and signed again.
5.3.4 Tablets, pills, capsules and granules are taken as tablets, pellets, granules and bags. The
ointmentsOintments and cream are taken as the unit in the branches and boxes, and the solution. Solution
preparations and injections are in units of branches and bottles, and the dosage should be marked.
5.3.5 The medicineMedicine with strong or toxic components should avoid reusing. The finishednot be
reused. Finished medicinal products with the same function or with the same toxicity decoction pieces should
not be superimposed.
5.3.6 Chinese Medicines injection should be prescribed separately.
5.3.7 The format of the prescription can be consistent with the electronic medical record.
5.4 Writing FormatWritten format of the prescription of Chinese medicines
WritingFor the written format of decoction pieces and finished Chinese medicinal product prescription should
meet the relevant requirements of the , local authority. requirements can apply. See Appendix AAnnex A for
writingwritten examples of decoction pieces and finished Chinese medicinal product prescription.
6 Management of prescription rightsofrights for Chinese medicine, the and
qualification for dispensation and delivery
6.1 ManagementModification of the prescription right of Chinese medicine
6.1.1 Modifications of prescription
Each item on a prescription written by the physicians mustphysician shall remain una
...